The US Food and Drug Administration (FDA) have issued a warning letter to drug manufacturing facility of KVK-Tech following an audit in April 2019.
The document was shared with the company for violating current good manufacturing practice (cGMP) regulations for completed pharmaceuticals. The FDA has declared that due to these cGMP breaches, the products of business are adulterated as per the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The failure of firm to properly collaborate co-eluting peaks during impurity testing of phentermine HCL capsules, which lead to its analysis failing to detect out-of-specification (OOS) outcomes for at least one lot of drug product. The FDA writes that in 2016, the company self-recognized this problem. Despite having trained the staff, the incorrect analysis was conducted, resulting in the batch remaining on the market.
Also, foreign particles discovered in a lot of methylphenidate oral solution were not properly examined. Although filtered out, there was insufficient examination of the origin and nature of the particles and their impact on drug quality.
Furthermore, data protection’s quality was observed by the FDA to be insufficient, involving the fact that data files could be altered or overwritten without being caught on audit trails on your stand-alone laboratory equipment.
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